Closure device and methods and systems for using same

Abstract

Embodiments of the present disclosure are directed to apical closure systems, devices, and methods and systems for use thereof, for closing surgical openings or defects in the wall of the heart.

Description

FIELD OF THE DISCLOSURE[0001]Embodiments of the present disclosure are directed to closure devices, more particularly, apical closure devices and methods and systems for use thereof, for closing surgical openings in the wall of the heart (for example).BACKGROUND OF THE DISCLOSURE[0002]Cardiovascular disease or cardiovascular diseases refers to the class of diseases that involve the heart or blood vessels (arteries and veins). This class of disease thus refers to any disease that affects the cardiovascular system any may include atherosclerosis (arterial disease), coronary artery disease, valvular heart disease, ischemic heart disease (IHD), or myocardial ischaemia. These diseases are characterized by reduced blood supply to the heart muscle, usually due to coronary artery disease (atherosclerosis of the coronary arteries). Depending on the symptoms and risk, treatment may be with medication, percutaneous coronary intervention (angioplasty) or conventional open-heart surgery.[0003]Be...

AI Technical Summary

Benefits of technology

[0012]The present invention provides for a Left Ventricle (LV) trans-apical procedure that has been developed for transcatheter aortic implants. The LV trans-apical access procedures may be conveniently used for the transcatheter treatment of mitral valve (both valve implant and valve repair).

[0047]In some embodiments, a delivery apparatus for delivering a ventricle closure to an access opening may comprise: a sheath for at least partly surrounding the closure device and defining a compartment to constrain the closure device to a delivery state in which the closure device is collapsed for delivery and implantation; and / or a guidewire lumen coupled to the sheath and positioned externally of the compartment for the closure device. Use of a guidewire lumen external to the compartment may facilitate delivery over a guidewire without the guidewire having to pass through the closure device itself. An advantage is that the closure device may avoid a self-closing valve or material for closing the guidewire aperture.

Problems solved by technology

In some cases, in addition, the valve malfunctioning may affect more than one heart valve at the same time.

Additionally, these approaches require arrest of the patient's heart.

These techniques are thus extremely invasive and are accompanied risk of death or serious complications, depending on the comorbidities and age of the patient.

Older patients, as well as more fragile ones, are sometimes ineligible for surgery because of elevated risks.

Specifically, if the replacement valve is not placed in the proper position relative to the implantation site, it can affect the safety and efficacy of the valve.

For example, in an aortic valve replacement, if the replacement valve is placed too high, it can lead to valve regurgitation, instability, coronary occlusion.

If the valve is placed too low, it can also lead to regurgitation, to AV / block and interference with the mitral valve.

Safely closing a surgical opening of the free wall of the ventricle can be a challenging procedure, even because it must be performed without any support of extracorporeal circulation.

Further, fragile tissues may lead to technical difficulties, especially when closing larger holes while being off-pump in high-risk elderly patients.

However, the conventional technique involves surgical access to the heart, which may result in the transventricular procedure remaining more invasive than the peripheral (transfemoral) procedure.

While this technique is said to achieve a reliable and tight fit, and offers the potential of delivering the occluder along a guidewire to the access opening, and in particular along the same guide wire used for implantation of the prosthetic valve, the occluder has not been adopted.

Thus, despite the progress made in the development of trans-apical aortic valve implant, closure of the access opening in the heart remains a major issue.

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